Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Jack Wilkinson, Calvin Heal, George A. Antoniou, Ella Flemyng, Zarko Alfirevic, Alison Avenell, Ginny Barbour, Nicholas J.L. Brown, John Carlisle, Mike Clarke, Patrick Dicker, Jo C. Dumville, Andrew Grey, Steph Grohmann, Lyle Gurrin, Jill Alison Hayden, James Heathers, Kylie Elizabeth Hunter, Toby Lasserson, Emily LamSarah Lensen, Tianjing Li, Wentao Li, Elizabeth Loder, Andreas Lundh, Gideon Meyerowitz-Katz, Ben W. Mol, Neil E. O'Connell, Lisa Parker, Barbara K. Redman, Lene Seidler, Kyle A. Sheldrick, Emma Sydenham, David Torgerson, Madelon Van Wely, Rui Wang, Lisa Bero, Jamie J. Kirkham, Jack Wilkinson

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Abstract

Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. Methods and analysis The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. Ethics and dissemination The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Original languageEnglish
Article numbere084164
JournalBMJ Open
Volume14
Issue number3
Number of pages8
ISSN2044-6055
DOIs
Publication statusPublished - 11. Mar 2024

Keywords

  • Randomized Controlled Trial
  • STATISTICS & RESEARCH METHODS
  • Systematic Review

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